Japanese Fund Moves Quickly to Invest in Promising Technology Against Malaria, Tuberculosis And Chagas Disease

TOKYO and NEW YORK, Nov. 7, 2013 /PRNewswire-USNewswire/ -- The Global Health Innovative Technology Fund (GHIT Fund), a new public health partnership that is bringing Japanese know-how and investment to the global fight against infectious diseases, announced today grants of US$5.7 million to six global partnerships working on innovative drugs and vaccines against malaria, tuberculosis and Chagas disease.

"Our six new investments in potential treatments for malaria, tuberculosis and Chagas disease, infections that afflict roughly one in seven of our world's population, are a definitive step forward for, and a clear exemplification of, Japanese innovation and its application to global health," said Dr. BT Slingsby, the CEO and executive director of the GHIT Fund.

"By ending the vicious cycle of infections, poverty and destabilized communities, new drugs and vaccines for the poorest people in the world can bring stability and build new markets around the world," said Dr. Kiyoshi Kurokawa, the chair of the board of the GHIT Fund.

For malaria, a disease that sickens more than 200 million people each year and kills more than 650,000, the GHIT Fund will fund four new research and development (R&D) investments. The first is with the Research Institute for Microbial Diseases (RIMD) at Osaka University, in partnership with the Medical Center for Translational Research, Osaka University Hospital and Gulu University in Uganda, for roughly US$735,000 to test their newly formulated BK-SE36 malaria vaccine. A recently published study revealed that the vaccine showed efficacy against severe malarial infections, making it a promising malaria vaccine candidate. In the initial trials in a malaria-prone region of Uganda, however, many vaccinated adult individuals failed to generate a strong immune response to the original BK-SE36. The research team will use the new grant to test whether adding CpG, a substance known as an adjuvant, can boost the subjects' response to the vaccine. Researchers agree that a vaccine is desperately needed to check malaria's spread in the developing world, as part of a multipronged approach that includes other tools like bednets, sprays and antimalarial drugs.

The second investment will go to Japan's Ehime University and the biotech company CellFree Sciences, both located in Matsuyama, Ehime Prefecture, in partnership with PATH, based in Seattle, Washington, for work with its Malaria Vaccine Initiative. The Fund will invest US$600,000 to identify novel targets of immunity and accelerate the development of malaria vaccines to support elimination and eradication. The project addresses one of the main challenges in developing malaria vaccines, in that only a tiny percentage of potential targets on the parasite surface have been screened for their vaccine potential. Scientists at Ehime University have developed an innovative wheat germ cell-free protein synthesis technology, which has proven to be highly effective in producing large numbers of high quality Plasmodium proteins. Using this technology, the partnership will produce specific proteins for the purpose of developing monoclonal antibodies that will be evaluated for their ability to block parasites from invading liver cells. This would enable prioritization of antigens for future vaccine development.

The third and largest award, of approximately US$2.6 million, was granted to Medicines for Malaria Venture (MMV) in partnership with Takeda Pharmaceutical Company Limited (Takeda) to study a promising new anti-malarial compound, DSM265, to clinical proof-of-concept stage. New compounds are urgently needed to fight malaria, as resistance to current medicines is growing. Artemisinin combination therapies are the current gold-standard anti-malarial treatments that combine fast-acting artemisinin derivatives with a long-acting partner drug. The new drug candidate, DSM265, which kills the malaria parasite through inhibition of an essential enzyme, is a compound with a long duration of action that could potentially be part of a new treatment for malaria, with potential for being part of a single dose cure. The compound recently entered clinical phase I studies in healthy human volunteers. If the planned studies show that it works safely and effectively, DSM265 could undergo later-stage development as a new option in the treatment of malaria.

An additional award of approximately US$575,000 was granted to MMV in partnership with Takeda for development and its formulation of ELQ300, an anti-malarial compound that is in earlier stages of development. ELQ300 has the potential to be given once a month to treat and prevent malarial infections, which would make it an important tool in the control of malaria. However, some additional work related to its formulation is needed before it can be tested in patients.

The GHIT Fund will also invest in candidate products for tuberculosis and Chagas disease. For tuberculosis, a disease that causes an estimated 8.6 million new cases and kills about 1.3 million people annually, the Fund will invest US$720,000 for early work on a novel vaccine candidate against tuberculosis being co-developed by the National Institute of Biomedical Innovation, Japan's Create Vaccine Co., Ltd. and Aeras, an international non-profit biotech based in Washington, DC. The vaccine is the first to target the patient's mucous membranes to keep TB from making an entry into the lungs. In mice, the vaccine added protection to BCG, the current vaccine against tuberculosis. BCG was invented nearly 90 years ago and provides insufficient protection to teenagers and adults, the group with the highest TB burden.

The sixth and final investment of approximately US$510,000 will fund an innovative drug discovery initiative between Eisai Co., Ltd. and the Broad Institute of MIT and Harvard for Chagas disease, a parasitic infection that afflicts poor communities in South and Central America. Currently there are no drugs against chronic Chagas infection, which affects an estimated 8 million people worldwide. Chronic infection causes cardiovascular disorders that often lead to death and the loss of quality of life.

The GHIT Fund is a public-private partnership between five Japanese pharmaceutical companies (Astellas Pharma Inc.; Daiichi Sankyo Company, Limited; Shionogi & Co., Ltd.; Eisai and Takeda), two government ministries and the Bill & Melinda Gates Foundation, launched in April 2013 with a potential five-year commitment of over US$100 million. It is the first fund to involve a consortium of pharmaceutical companies, government and civil society working together to support research and development for neglected diseases. The combination of Japan's government and its pharmaceutical industry—the third largest in the world—brings a powerful engine of knowledge and innovation to the development of medications for the developing world.

About the RFPsThe GHIT Fund received 28 full proposals of RFP 2013-001 by the deadline of June 15, 2013 and conducted a proposal eligibility assessment. Eventually, 25 proposals were eligible and three proposals were ineligible. In order to maximize the use of public funds and donations, and to guarantee transparency, fairness and accountability, a double "peer review" process has been put into effect, through which an independent expert selection committee processes grant proposals for final review and approval by the Board of Directors. The board will use a variety of factors and priorities to determine the spectrum and scope for each round of proposals.

The GHIT Fund also announced today the second round of its Drug Discovery Screening Platform to facilitate the screening of compound libraries for identification of novel compounds for malaria, tuberculosis, and neglected tropical diseases. The GHIT Fund has facilitated and funded 13 partnerships between Japanese and non-Japanese organizations at the first round of the proposal, issued in April 2013. Interested partnerships are required to submit the contact form, which is available on the GHIT Fund website, by email to RFPResponse@ghitfund.org, no later than 5:00pm JST on January 31, 2014.